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Synergy Disc Intervertebral Distractor (Paddle Spreader)
EUDAMEDClass I (EU MDR)
Ref 1077-5170Model UDI50019 - Intervertebral Distractor (Paddle Spreader)
Identity
- Device Name
- Synergy Disc Intervertebral Distractor (Paddle Spreader) EUDAMED
- Model / Reference
- UDI50019 - Intervertebral Distractor (Paddle Spreader) EUDAMED1077-5170 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M670107751700I EUDAMED
- Basic UDI-DI
- ++M670UDI50019XN EUDAMED
- EMDN Code
- L11050199 VERTEBRAL SURGERY SPREADERS AND RETRACTORS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Synergy Disc Intervertebral Distractor (Paddle Spreader) by Synergy Spine Solutions Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++M670UDI50019XN | Class I | Active |
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Manufacturer
- Manufacturer
- Synergy Spine Solutions Inc.
- EUDAMED SRN
- US-MF-000014165
- Authorised Representative
- MedNet EC-REP III GmbH DE-AR-000011191
Sources (1)
- EUDAMED b37ca1c5-ceef-4104-86e5-56d9125d7434 61 fields · synced Jun 18, 2026